Dynamic device therapy control for treating post myocardial infarction patients

ABSTRACT

A cardiac rhythm management system includes an implantable device executing a dynamic pacing algorithm after an myocardial infarction (MI) event. The dynamic pacing algorithm dynamically adjusts one or more pacing parameters based on a person&#39;s gross physical activity level. Examples of the one or more pacing parameters include atrioventricular pacing delays and pacing channels/sites. The dynamic pacing algorithm provides for improved hemodynamic performance when a person&#39;s metabolic need is high, and post MI remodeling control when the person&#39;s metabolic need is low.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is related to co-pending, commonly assigned, U.S.patent application Ser. No. 09/962,852, “EVOKED RESPONSE SENSING FORISCHEMIA DETECTION,” filed on Sep. 25, 2001, U.S. patent applicationSer. No. 10/038,936, “METHOD AND APPARATUS FOR MEASURING LEFTVENTRICULAR PRESSURE,” filed on Jan. 4, 2002, U.S. patent applicationSer. No. 10/005,184, “METHOD AND APPARATUS FOR MINIMIZING POST-INFARCTVENTRICULAR REMODELING,” filed on Dec. 5, 2001, U.S. patent applicationSer. No. 10/314,910, “METHOD AND APPARATUS FOR OPTIMIZING VENTRICULARSYNCHRONY DURING DDD RESYNCHRONIZATION THERAPY USING ADJUSTABLEATRIO-VENTRICULAR DELAYS,” filed on Dec. 9, 2002, U.S. patentapplication Ser. No. 10/314,899, “METHOD AND APPARATUS FOR OPTIMIZINGSTROKE VOLUME DURING DDD RESYNCHRONIZATION THERAPY USING ADJUSTABLEATRIO-VENTRICULAR DELAYS,” filed on Dec. 9, 2002, and U.S. patentapplication Ser. No. 10/703,175 “A DUAL-USE SENSOR FOR RATE RESPONSIVEPACING AND HEART SOUND MONITORING,” filed on Nov. 6, 2003, which arehereby incorporated by reference in their entirety.

FIELD OF THE INVENTION

This document generally relates to cardiac rhythm management systems andparticularly, but not by way of limitation, to such systems providingfor cardiac pacing after myocardial infraction.

BACKGROUND

The heart is the center of a person's circulatory system. It includes anelectro-mechanical system performing two major pumping functions. Theheart includes four chambers: right atrium (RA), right ventricle (RV),left atrium (LA), and left ventricle (LV). The left portions of theheart, including LA and LV, draw oxygenated blood from the lungs andpump it to the organs of the body to provide the organs with theirmetabolic needs for oxygen. The right portions of the heart, includingRA and RV, draw deoxygenated blood from the body organs and pump it tothe lungs where the blood gets oxygenated. These pumping functions areaccomplished by cyclic contractions of the myocardium (heart muscles).Each cycle, known as the cardiac cycle, includes systole and diastole.Systole is the ejection phase of the cardiac cycle, during which theventricles eject blood. Diastole is the relaxation phase of the cardiaccycle. The efficiency of the pumping functions, indicative whether theheart is normal and healthy, is indicated by measures of hemodynamicperformance, such as parameters related to intracardiac blood pressuresand cardiac output.

In a normal heart, the sinus node, the heart's natural pacemaker,generates electrical impulses, called action potentials, that propagatethrough an electrical conduction system to various regions of the heartto excite the myocardial tissues of these regions. Coordinated delays inthe propagations of the action potentials in a normal electricalconduction system cause the various portions of the heart to contract insynchrony to result in efficient pumping functions indicated by a normalhemodynamic performance. A blocked or otherwise abnormal electricalconduction and/or deteriorated myocardial tissue cause dysynchronouscontraction of the heart, resulting in poor hemodynamic performance,including a diminished blood supply to the heart and the rest of thebody. The condition where the heart fails to pump enough blood to meetthe body's metabolic needs is known as heart failure.

Myocardial infarction (MI) is the necrosis of portions of the myocardialtissue resulted from cardiac ischemia, a condition in which themyocardium is deprived of adequate oxygen and metabolite removal due toan interruption in blood supply. As a physiological compensatorymechanism that acts to increase cardiac output in response to MI, the LVdiastolic filling pressure increases as the pulmonary and venous bloodvolume increases. This increases the LV preload (stress on the LV wallbefore its contracts to eject blood), as measured by the leftventricular end diastolic pressure (LVEDP). One effect is theprogressive change of the LV shape and size, a processes referred to asremodeling. Remodeling is initiated in response to a redistribution ofcardiac stress and strain caused by the impairment of contractilefunction in the infarcted area as well as in nearby and/or interspersedviable myocardial tissue with lessened contractility due to the infarct.The remodeling starts with expansion of the infracted area andprogresses to a chronic, global expansion in the size and change in theshape of the entire LV. Although the process is initiated by thecompensatory mechanism that increases cardiac output, the remodelingultimately leads to further deterioration and dysfunction of themyocardium. Consequently, post MI patients experience impairedhemodynamic performance and have a significantly increased risk ofdeveloping heart failure.

For these and other reasons, there is a need to control post MIremodeling and improve hemodynamic performance.

SUMMARY

A cardiac rhythm management system includes an implantable deviceexecuting a dynamic pacing algorithm after a myocardial infarction (MI)event. The dynamic pacing algorithm provides for improved hemodynamicperformance when a person's metabolic need is high and post MIremodeling control when the person's metabolic need is low.

In one embodiment, an implantable medical device includes a sensingcircuit, a pacing circuit, an activity sensor, and a pacing controller.The sensing circuit senses at least one electrogram. The pacing circuitdelivers pacing pulses. The activity sensor senses an activity level.The pacing controller includes a dynamic pacing parameter controller, anMI detector, and a pacing algorithm selector. The dynamic pacingparameter controller receives an activation signal and, after theactivation signal is received, controls one or more pacing parametersbased on at least the activity level. The MI detector detects a signalindicative of an MI event. The pacing algorithm selector generates theactivation signal after the signal indicative of the MI event isdetected. In a further embodiment, a cardiac rhythm management systemincludes the implantable medical device and an external systemcommunicating with the implantable medical device via telemetry. Theexternal system includes a user input to receive commands controllingoperations of the implanted medical device.

In one embodiment, a method for operating an implantable pacemakerincludes detecting a signal indicative of an MI event and executing adynamic pacing algorithm after the signal indicative of the MI event isdetected. The execution of the dynamic pacing algorithm includes sensingan activity level, dynamically adjusting one or more pacing parametersbased on at least the activity level, sensing at least one electrogram,and delivering pacing pulses.

In one embodiment, a cardiac pacing method includes sensing an activitylevel and comparing the activity level to a predetermined threshold. Ifthe activity level exceeds the predetermined threshold, a cardiacresynchronization therapy (CRT) pacing algorithm is executed. If theactivity level does not exceed the predetermined threshold, a remodelingcontrol therapy (RCT) pacing algorithm is executed.

This Summary is an overview of some of the teachings of the presentapplication and not intended to be an exclusive or exhaustive treatmentof the present subject matter. Further details about the present subjectmatter are found in the detailed description and appended claims. Otheraspects of the invention will be apparent to persons skilled in the artupon reading and understanding the following detailed description andviewing the drawings that form a part thereof, each of which are not tobe taken in a limiting sense. The scope of the present invention isdefined by the appended claims and their equivalents.

BRIEF DESCRIPTION OF THE DRAWINGS

In the drawings, which are not necessarily drawn to scale, like numeralsdescribe similar components throughout the several views. The drawingsillustrate generally, by way of example, but not by way of limitation,various embodiments discussed in the present document. The drawing arefor illustrative purposes only and not to scale nor anatomicallyaccurate.

FIG. 1 is a flow chart illustrating an embodiment of a method for postMI cardiac pacing.

FIG. 2 is an illustration of an embodiment of a cardiac rhythmmanagement (CRM) system and portions of an environment in which it isused.

FIG. 3 is a block diagram showing one embodiment of portions of thecircuit of an implantable device of the CRM system.

FIG. 4 is a block diagram showing one embodiment of portions of thecircuit of the implantable device and portions of the circuit of anexternal system of the CRM system.

FIG. 5 is a block diagram showing one further embodiment of portions ofthe circuit of the implantable device and portions of the circuit of theexternal system of the CRM system.

FIG. 6 is a flow chart illustrating an embodiment of a method foroperating an implantable medical device to deliver post MI cardiacpacing.

DETAILED DESCRIPTION

In the following detailed description, reference is made to theaccompanying drawings which form a part hereof, and in which is shown byway of illustration specific embodiments in which the invention may bepracticed. These embodiments are described in sufficient detail toenable those skilled in the art to practice the invention, and it is tobe understood that the embodiments may be combined, or that otherembodiments may be utilized and that structural, logical and electricalchanges may be made without departing from the spirit and scope of thepresent invention. The following detailed description provides examples,and the scope of the present invention is defined by the appended claimsand their equivalents.

It should be noted that references to “an”, “one”, or “various”embodiments in this disclosure are not necessarily to the sameembodiment, and such references contemplate more than one embodiment.

This document discusses, among other things, a method and system fordelivering cardiac pacing therapy to post MI patients. Many post MIpatients need both a therapy for improving hemodynamic performance and atherapy for controlling remodeling. The two therapies are delivered byexecuting a dynamic pacing algorithm, i.e., executing two pacingalgorithms or applying two sets of pacing parameters alternately,depending on the patient's instant need and conditions. In thisdocument, a “dynamic pacing algorithm” includes a comprehensive pacingalgorithm that includes two or more pacing algorithms dynamicallyselected to be executed one at a time based on a command or signal, or apacing algorithm that includes one or more pacing parameters dynamicallyadjusted based on a command or signal.

FIG. 1 is a flow chart illustrating an embodiment of such a post MIpacing method. In one embodiment, a cardiac resynchronization therapy(CRT) provides for an approximately optimal hemodynamic performance, anda remodeling control therapy (RCT) reduces the degree of post MIremodeling. In one embodiment, a CRT pacing algorithm is executed withone or more pacing parameters approximately optimized to maximize ameasure of hemodynamic performance. Examples of determining such pacingparameters are discussed in U.S. patent application Ser. No. 10/314,910,“METHOD AND APPARATUS FOR OPTIMIZING VENTRICULAR SYNCHRONY DURING DDDRESYNCHRONIZATION THERAPY USING ADJUSTABLE ATRIO-VENTRICULAR DELAYS,”and U.S. patent application Ser. No. 10/314,899, “METHOD AND APPARATUSFOR OPTIMIZING STROKE VOLUME DURING DDD RESYNCHRONIZATION THERAPY USINGADJUSTABLE ATRIO-VENTRICULAR DELAYS,” both filed on Dec. 9, 2002,assigned to Cardiac Pacemakers, Inc., which are hereby incorporated byreference in their entirety. An RCT pacing algorithm is executed toreduce the degree of remodeling by redistributing the loading or stresson the LV wall. An example of post MI RCT is discussed in U.S. patentapplication Ser. No. 10/005,184, “METHOD AND APPARATUS FOR MINIMIZINGPOST-INFARCT VENTRICULAR REMODELING,” filed on Dec. 5, 2001, assigned toCardiac Pacemakers, Inc., which is hereby incorporated by reference intheir entirety. Generally, the CRT and RCT cannot be deliveredsimultaneously because of conflicts between their effects. For example,pacing parameters that provide for most efficient remodeling control maynot maximize hemodynamic performance. One therapy for treating post MIpatients is to control the progress of post MI remodeling by reducingthe preload in the infract region. Pacing pulses are delivered with ashort atrioventricular (AV) delay to reduce the stress to this regionprior to contraction. However, pacing with the short AV delay may resultin reduced hemodynamic performance. For example, if the heart beingpaced with the short AV delay has a normal ventricular conduction(Purkinje) system, the pacing lowers measures of hemodynamic performancesuch as the degree of ventricular synchrony and the cardiac output. Oneconsequent problem is that when a post MI patient becomes active, thepacing with the short AV delay may limit the cardiac output and hence,prevent the heart from pumping sufficient blood to meet the patient'smetabolic need. One solution is to deliver the CRT and RCT on analternating basis, depending on the metabolic need of the post MIpatient, such that the pacing provides for optimal hemodynamicperformance when the metabolic need is high, and post MI remodelingcontrol when the metabolic need is low. In other words, a comprehensivetherapy is delivered by executing a dynamic pacing algorithm, and thatincludes executing at least two specific pacing algorithms, such as theCRT and RCT pacing algorithms, on an alternating basis.

As illustrated in FIG. 1, an activity level is sensed at 100. Theactivity level is a measure of the intensity of the patient's grossphysical activity, which in turn indicates the patient's metabolic needfor oxygenated blood. In one embodiment, an acceleration signal issensed as the activity level, such as by using an accelerometerimplanted in the patient. In another embodiment, the patient's minuteventilation is sensed as the activity level, such as by using animpedance sensor implanted in the patient. In another embodiment, theheart rate of the patient is sensed as the activity level from anelectrocardiogram or electrogram. The heart rate is usable as anindication of the activity level when it is an intrinsic heart rate,such as when the patient receives VDD mode pacing.

The activity level is compared to a predetermined threshold at 110. Thethreshold corresponds to an activity level above which a need to improveor maintain hemodynamic performance is indicated. The threshold isdetermined based on the patient's physiological condition, lifestyle,and other factors indicative of a need for improving hemodynamics bypacing. In one embodiment, the threshold is determined empirically basedon statistical analysis of data from multiple patients. In oneembodiment, the threshold is determined based on each individualpatient's circumstances, such as physiological conditions and desirablelifestyle. In one embodiment, the threshold is adaptive and adjusted inresponse to changes the patient's physiological condition, lifestyle,and other factors.

If the activity level exceeds the predetermined threshold at 120, theCRT pacing algorithm is executed at 130. If the activity level does notexceed the predetermined threshold at 120, the RCT pacing algorithm isexecuted at 140. In one embodiment, the threshold corresponds to anactivity level above which the patient is indicated as being exercising(or conducting a physical activity with the intensity comparable to thatof exercising). The patient receives CRT when exercising and RCT whennot exercising. In one embodiment, the threshold corresponds to anactivity level below which the patient is indicated as being sleeping.The patient receives RCT while sleeping and CRT while being awake. Inone embodiment, executing the CRT pacing algorithm includes selecting aset of pacing parameter values to approximately maximize a measure ofhemodynamic performance, and executing the RCT pacing algorithm includesselecting another set of pacing parameter values providing forapproximately optimal preload reduction in the infarcted area. Studieshave shown that the two sets of pacing parameter values aresignificantly different. In one embodiment, the pacing parameters thatare used but with distinct values for the CRT and RCT include pacingsites, AV delays, and/or interventricular delays. In one specificembodiment, the CRT pacing algorithm uses one or more AV delays that aresignificantly longer than those of the RCT pacing algorithm.

In one embodiment, the activity level is sensed and compared to thethreshold continuously. In another embodiment, the activity level issensed and compared to the threshold according to a predeterminedschedule. In another embodiment, the activity level is sensed andcompared to the threshold on a periodical basis. The pacing algorithmbeing executed changes when the outcome of the comparison changes.

It is to be understood that the CRT and RCT are used to illustrate themethod by way of example, but not by way of limitation. The methoddiscussed herein using the CRT and RCT as examples applies to a pacingtherapy with two or more pacing algorithms dynamically selected andexecuted to serve a plurality of therapy objectives. In general, themethod discussed above, using the CRT, RCT, and activity level asexamples, is generally applicable to a comprehensive treatment of apatient with any abnormal condition, where the comprehensive treatmentincludes a first therapy, a second therapy, and a signal or parameterindicating when the first therapy is to be delivered and when the secondtherapy is to be delivered.

FIG. 2 is a schematic/block diagram illustrating one embodiment ofportions of a CRM system 200 and portions of the environment in which itis used. CRM system 200 includes a cardiac pacing system to perform themethod discussed above with reference to FIG. 1. In one embodiment, CRMsystem 200 includes an implantable system 235, an external system 255,and a telemetry link 245 providing for bidirectional communicationbetween implantable system 235 and external system 255. Implantablesystem 235 includes an implantable device 240 and an implantable leadsystem 210. Implantable device 240 is implanted within a body 202 andelectrically connected to a heart 201 via lead system 210. Implantabledevice 240 is an implantable pacemaker or any implantable medical devicewith a pacemaker circuit, such as a pacemaker-defibrillator. In oneembodiment, the implantable pacemaker provides for the CRT pacing andRCT pacing. In one embodiment, lead system 210 includes an atrial pacinglead having one or more electrodes placed in the right atrium, and oneventricular pacing lead having one or more electrodes placed in aventricle. In another embodiment, multiple ventricular sites are paced,and lead system 210 includes multiple ventricular pacing leads eachhaving one or more electrodes to be placed in the LV and/or the RV.

In one embodiment, external system 255 is a patient management systemincluding an external device 250 in proximity of implantable device 240,a remote device 270 in a relatively distant location, and atelecommunication network 260 linking external device 250 and remotedevice 270. The patient management system allows access to implantablesystem 235 from a remote location, for purposes such as monitoringpatient status and adjusting therapies without the need of the patient'spresence. In another embodiment, external system 255 includes aprogrammer that provides for patient monitoring, device monitoring, anddevice programming.

In one embodiment, telemetry link 245 is an inductive telemetry link. Inanother embodiment, telemetry link 245 is a far-field radio-frequencytelemetry link. In one embodiment, telemetry link 245 provides for datatransmission from implantable device 240 to external system 255. Thismay include, for example, transmitting real-time physiological dataacquired by implantable device 240, extracting physiological dataacquired by and stored in implantable device 240, extracting therapyhistory data stored in implantable device 240, and extracting dataindicating an operational status of implantable device 240 (e.g.,battery status and lead impedance). In a further embodiment, telemetrylink 245 provides for data transmission from external system 255 toimplantable device 240. This may include, for example, programmingimplantable device 240 to acquire physiological data, programmingimplantable device 240 to perform at least one self-diagnostic test(such as for a device operational status), and programming implantabledevice 240 to deliver at least one therapy, including selecting pacingalgorithms and programming therapy parameters.

FIG. 3 is a block diagram showing one embodiment of portions the circuitof implantable device 240. Implantable device 240 includes a sensingcircuit 320, a pacing circuit 322, an activity sensor 324, and a pacingcontroller 330. In one embodiment, implantable device 240 includes ahermetically sealed metal can to house at least portions of theelectronics.

Sensing circuit 320 and pacing circuit 322 are electrically connected toheart 201 through lead system 210. Lead system 210 includes one or moreleads having electrodes placed in intracardiac sites. Sensing circuit320 senses one or more electrograms each from one interested region inheart 201. Pacing circuit 322 includes pacing channels each individuallycontrollable to deliver pacing pulses to one targeted region in heart201. In one embodiment, sensing circuit 320 senses electrograms from anatrial region and a ventricular region. Pacing circuit 322 deliverspacing pulses to at least the ventricular site with a programmable AVdelay. In one embodiment, sensing circuit 320 senses electrograms froman atrial region and a plurality of ventricular regions. Pacing circuit322 delivers pacing pulses to one or more of the ventricular regions,with individually programmable AV delays. Each region corresponds to atleast one electrode site. When pacing pulses are delivered to two ormore ventricular regions, the timing of the delivery is controlled witheither individually controlled AV delays or with one AV delay and one ormore interventricular delays. For example, if pacing pulses aredelivered to an RV site and an LV site, in one embodiment, RV pacingpulses are each delivered with an AV delay for RV, AVD_(RV), and LVpacing pulses are each delivered with an AV delay for LV, AVD_(LV). Inan alternative embodiment, RV pacing pulses are each delivered with anAV delay for RV, AVD_(RV), and LV pacing pulses are each delivered withan interventricular delay between RV and LV, IVD_(LV-RV), whereIVD_(LV-RV)=AVD_(LV)−AVD_(RV).

Activity sensor 324 senses an activity level being a measure of theintensity of the patient's gross physical activities. In one embodiment,activity sensor 324 includes a heart rate monitor to detect a heart rateindicative of the activity level. In one specific embodiment, the heartrate monitor includes an event detector to detect ventricularcontractions from a ventricular electrogram, measures the time intervalbetween two consecutively detected ventricular contractions, andcalculates the heart rate based on the time interval. In anotherspecific embodiment, the heart rate monitor includes an event detectorto detect atrial contractions from an atrial electrogram, measures thetime interval between two consecutively detected atrial contractions,and calculates the heart rate based on the time interval. In oneembodiment, activity sensor 324 includes an accelerometer to sense anacceleration signal indicative of the activity level. In one specificembodiment, the accelerometer is housed within the hermetically sealedcan. In another specific embodiment, the accelerometer is incorporatedinto a lead of lead system 210, so as to be placed near or within theheart. In one embodiment, activity sensor 324 includes a respiratorysensor to sense a signal indicative of the patient's minute ventilation.In one specific embodiment, the respiratory sensor is an impedancesensor sensing thoracic impedance indicative of the pulmonary volume.

Pacing controller 330 controls the delivery of pacing pulses byexecuting a pacing algorithm and includes a dynamic pacing parametercontroller 332, a pacing algorithm selector 334, and a myocardialinfarction detector (MI detector) 336. In one embodiment, pacingcontroller 330 controls whether and when a pacing pulse is deliveredfrom each of the pacing channels of pacing circuit 322. This includescontrol of pacing sites (whether to deliver a pacing pulse to anelectrode site), control of AV delays (when to deliver a ventricularpacing pulse after a sensed or paced atrial event), and control ofinterventricular delays (when to deliver a pacing pulse to oneventricular site after a sensed or paced event in another ventricularsite).

Dynamic pacing parameter controller 332 supports the execution of adynamic pacing algorithm by dynamically adjusting one or more pacingparameters in response to a changing activity level. In one embodiment,dynamic pacing parameter controller 332 includes an AV delay adjuster todynamically adjusting at least one AV delay based on at least theactivity level. In one specific embodiment, the AV delay adjusterincludes an AV delay selector to dynamically select a value for the atleast one AV delay from a plurality of preset AV delay values based onat least the activity level. When the dynamic pacing algorithm includespacing multiple ventricular sites, in one embodiment, dynamic pacingparameter controller 332 includes the AV delay adjuster adjusts multipleAV delays. In an alternative embodiment, dynamic pacing parametercontroller 332 includes the AV delay adjuster to adjust one AV delay andan interventricular delay adjuster to adjust at least oneinterventricular delay. In one specific embodiment, the interventriculardelay adjuster includes an interventricular delay selector todynamically select a value for the at least one interventricular delayfrom a plurality of preset interventricular delay values based on atleast the activity level. In one embodiment, dynamic pacing parametercontroller 332 further includes a pacing channel selector to dynamicallyselect one or more pacing channels from a plurality of preset pacingchannels based on at least the activity level. In one embodiment,dynamic pacing parameter controller 332 includes a parameter receiver toreceive values for the one or more pacing parameters. In one specificembodiment, the parameter receiver receives the preset AV delays,interventricular delays, and/or pacing channels as they are programmedinto implantable device 240. Dynamic pacing parameter controller 332includes an activity level comparator to compare the sensed activitylevel to a threshold level indicative of a need for the pacing parameteradjustment. In one embodiment, the activity level comparator comparesthe sensed activity level to one or more predetermined activity levelthresholds to produce two or more activity level ranges. Each activitylevel range corresponds to a predetermined set of one or more pacingparameter values. In one embodiment, such as in the example of thealternating execution of the CRT and RCT pacing algorithms, eachpredetermined set of one or more pacing parameter values corresponds toone of the pacing algorithms being part of a dynamic pacing algorithm.In this embodiment, dynamic pacing parameter controller 332 effectivelyswitches pacing algorithms by adjusting pacing parameters. In onespecific embodiment, dynamic pacing parameter controller 332 changes thepacing algorithm being executed from the CRT pacing algorithm to the RCTpacing algorithm by shortening one or more AV delays, adjusting one ormore interventricular delays, and/or reselecting one or more pacingchannels.

Pacing algorithm selector 334 selects one or more pacing algorithms tobe executed by pacing controller 330 in response to an algorithmselection signal. When the algorithm selection signal calls for adynamic pacing algorithm which requires dynamic pacing parameteradjustments during the execution, pacing algorithm selector 334generates an activation signal to activate dynamic pacing parametercontroller 332. In one embodiment, pacing algorithm selector 334includes a timer to time a predetermined time period starting with theMI event and generates the activation signal after the predeterminedperiod expires. Because post MI remodeling progresses in stages, a postMI RCT pacing is timed to start and/or be adjusted at appropriate times.

MI detector 336 detects a signal indicative of an MI event and producesthe algorithm selection signal calling for the dynamic pacing algorithmin response to a detection. Thus, pacing algorithm selector 334generates the activation signal to activate dynamic pacing parametercontroller 332 after the signal indicative of the MI event is detected.In one embodiment, MI detector 336 includes a command receiver toreceive an external activation command sent to implantable device 240 asthe signal indicative of the MI event. In one specific embodiment, theexternal activation command is issued by a physician or other caregiverin response to the diagnosis of MI. This embodiment is suitable for use,for example, when implantable device 240 is implanted into a patienthaving experienced MI. In one embodiment, MI detector 336 detects thesignal indicative of the MI event from the physiological signals sensedby implantable device 240. In one embodiment, MI detector 336 includesan ischemia detector housed in implantable device 240. In one specificembodiment, MI detector 336 includes an electrogram-based ischemiadetector to detect an ischemia as the signal indicative of the MI event.One example of the electrogram-based ischemia detector is discussed inU.S. patent application Ser. No. 09/962,852, entitled “EVOKED RESPONSESENSING FOR ISCHEMIA DETECTION,” filed on Sep. 25, 2001, assigned toCardiac Pacemakers, Inc., which is incorporated herein by reference inits entirety. In another specific embodiment, MI detector 336 includesan impedance-based ischemia detector. The ischemia detector includes anelectrical impedance based sensor using a low carrier frequency (e.g.100 Hz) and an ischemia analyzer running an automatic ischemia detectionalgorithm to detect an ischemic condition from the electrical impedancesignal. Tissue electrical impedance has been shown to increasesignificantly during ischemia, as discussed in Min, et al. InternationalJournal of Bioelectromagnetism, 5(1):53–56 (2003). The ischemia detectorsenses low frequency electrical impedance signal between electrodesinterposed in the heart, and detects the ischemia as abrupt changes inimpedance (such as abrupt increases in value). In another embodiment,the ischemia detector includes a local heart motion based sensorutilizing an accelerometer located within a lead body positioned on orin the heart and an ischemia analyzer running an automatic ischemiadetection algorithm to detect an ischemic condition from theacceleration signal. The ischemia detector detects ischemia as an abruptdecrease in the amplitude of local cardiac accelerations. Detecting thesignal indicative of the MI event by implantable device 240 is suitable,for example, when the implantable device is implanted into a patienthaving not experienced MI but is at significant risk of a future MIevent.

FIG. 4 is a block diagram showing one embodiment of portions of thecircuit of implantable device 240 and portions of the circuit ofexternal system 255. Implantable device 240 communicates with externalsystem 255 via telemetry link 245.

External system 255 includes a user input 456 to receive commands fromthe physician or other caregiver controlling operations of implantabledevice 240. User input 456 receives a user activation command and issuesthe external activation command, which is transmitted to implantabledevice 240 via telemetry 245. In one embodiment, user input 456 alsoreceives values for the pacing parameters such as the preset AV delays,interventricular delays, and pacing channels. In one embodiment, userinput 456 includes an on/off selector allowing an entry of the useractivation command by an on-selection. In another embodiment, user input456 includes toggle switch allowing an entry of the user activationcommand by switching to the on-position. In one embodiment, user input456 includes numerical entry fields to receive values for the pacingparameters, such as the preset AV delay values, the presetinterventricular delay values, and the preset pacing channels. Thepacing parameter values are programmed into pacing controller 330 ofimplantable device 240 via telemetry.

In one embodiment, external system 255 includes a programmer with userinput 456. In another embodiment, external system 255 is a patientmanagement system including external device 250, network 260, and remotedevice 270. In one embodiment, external device 250 includes user input456 to allow the physician or other caregiver to enter the externalactivate command and/or the preset pacing parameter values in thepresence of the patient. In one embodiment, remote device 270 includesuser input 456 to allow the physician or other caregiver to enter theexternal activate command and/or the preset pacing parameter values froma remote location, eliminating the need of directly seeing the patientbefore delivering a new therapy.

FIG. 5 is a block diagram showing one further embodiment of portions ofthe circuit of implantable device 240 and portions of the circuit ofexternal system 255. In this embodiment, implantable device 240 furtherincludes a hemodynamic performance sensor 526 to sense a signalindicative of hemodynamic performance. In one embodiment, pacingcontroller 330 includes a signal analyzer to receive and analyze thesignal indicative of hemodynamic performance. Pacing algorithm selector334 determines whether to activate or deactivate dynamic pacingparameter controller 332 based on the signal indicative of hemodynamicperformance. For example, pacing algorithm selector 334 stops executinga dynamic pacing algorithm that includes the CRT and RCT pacingalgorithms, and starts executing a CRT-only pacing algorithm, when ameasure of hemodynamic performance reaches an intolerable level whileexecuting the RCT pacing algorithm. In another embodiment, dynamicpacing parameter controller 332 adjusts the one or more pacingparameters based on the activity level and the signal indicative ofhemodynamic performance, so as to ensure that the parameter adjustmentdoes not cause intolerable hemodynamic performance. In anotherembodiment, pacing controller 330 uses the signal indicative ofhemodynamic performance to dynamically optimizing pacing parameters forthe CRT.

In one embodiment, hemodynamic performance sensor 526 includes a minuteventilation sensor. In one specific embodiment, in which activity sensor324 includes a minute ventilation sensor, the minute ventilation sensoris used as both activity sensor 324 and hemodynamic performance sensor526.

In one embodiment, hemodynamic performance sensor 526 includes anacoustic sensor to sense heart sounds. In one specific embodiment, thesignal analyzer includes a heart sound analyzer to detect first heartsounds (S1) and measure an S1 amplitude and/or duration. In anotherspecific embodiment, the signal analyzer includes a heart sound analyzerto detect third heart sounds (Ss) and measure an S3 amplitude. In oneembodiment, the acoustic sensor includes an accelerometer. In onespecific embodiment, the acoustic sensor and activity sensor areimplemented as one single accelerometer, for example, as discussed inU.S. patent application Ser. No. 10/703,175, “A DUAL-USE SENSOR FOR RATERESPONSIVE PACING AND HEART SOUND MONITORING,” filed on Nov. 6, 2003,assigned to Cardiac Pacemakers, Inc., which is hereby incorporated byreference in their entirety.

In one embodiment, hemodynamic performance sensor 526 includes apressure sensor to sense a signal indicative of an LV pressure. Thesignal analyzer includes a pressure analyzer to calculate the maximumpositive derivative of the LV pressure, denoted by the term “LV+dp/dt.”LV+dp/dt is a measure of LV synchrony, also known LV contractility. TheLV pressure is measured directly or indirectly by sensing anotherpressure having a known or predictable relationship with the LVpressure. Examples of pressures having known or predictablerelationships with the LV pressure during all or a portion of thecardiac cycle include an LA pressure and a coronary vein pressure. Onespecific example of measuring the LV pressure using a coronary veinpressure sensor is discussed in U.S. patent application Ser. No.10/038,936, “METHOD AND APPARATUS FOR MEASURING LEFT VENTRICULARPRESSURE,” filed on Jan. 4, 2002, assigned to Cardiac Pacemakers, Inc.,which is hereby incorporated by reference in its entirety. In oneembodiment, such as a CRT, one or more pacing parameters are optimizedfor a maximum LV+dp/dt.

In one embodiment, hemodynamic performance sensor 526 includes a strokevolume sensor to sense a signal indicative of a stroke volume. Anexample of stroke volume sensing is discussed in U.S. Pat. No.4,686,987, “BIOMEDICAL METHOD AND APPARATUS FOR CONTROLLING THEADMINISTRATION OF THERAPY TO A PATIENT IN RESPONSE TO CHANGES INPHYSIOLOGIC DEMAND,” assigned to Cardiac Pacemakers, Inc., which isincorporated herein by reference in their entirety. In one embodiment,such as a CRT, one or more pacing parameters are optimized for a maximumstroke volume.

In the embodiment of FIG. 5, external system 255 further includes asignal receiver 558, a presentation device 557, and an externalcontroller 559. Signal receiver 558 receives signals acquired byimplantable device 240, including one or more electrograms, the activitylevel, and the signal indicative of hemodynamic performance.Presentation device 557 presents the received signals to the physicianor other caregiver. In one embodiment, the physician or other caregiverresponds by entering the user activation command and/or the pacingparameter values through user input 456. In one embodiment, externalcontroller 559 analyzes the received signals and automatically issuesthe external activation command when deemed necessary.

In one embodiment, external system 255 includes a programmer with userinput 456, signal receiver 558, presentation device 557, and externalcontroller 559. In another embodiment, external system 255 is a patientmanagement system including external device 250, network 260, and remotedevice 270. The physical distribution of user input 456, signal receiver558, presentation device 557, and external controller 559 in externalsystem 255 depends on overall considerations of factors such as need,convenience of use, and feasibility of implementation.

FIG. 6 is a flow chart illustrating an embodiment of a method foroperating an implantable medical device to deliver post MI cardiacpacing. In one embodiment, the method is performed by using CRM system200, which includes implantable device 240.

A signal indicative of an MI event is being detected at 600. In oneembodiment, detecting the signal indicative of the MI event includesreceiving an external activation command issued in response to adiagnosis of MI. The external activation signal is considered as thesignal indicative of the MI event. In another embodiment, the signalindicative of the MI event is a signal indicative of ischemia detectedfrom a physiological signal such as an electrogram, an impedance signal,or a cardiac wall motion signal using one or more implantable ischemiadetectors, such as those discussed above with reference to FIG. 3.

If the signal indicative of the MI event is detected at 610, a dynamicpacing algorithm is executed at 620. In one embodiment, a predeterminedtime period starts when the signal indicative of the MI event isdetected, and the execution of the dynamic pacing algorithm starts uponthe expiration of the predetermined time period.

The pacing algorithm execution at 620 includes sensing an activity levelat 622, dynamically adjusting one or more pacing parameters based on atleast the activity level at 624, sensing at least one electrogram at626, and delivering pacing pulses at 628. The activity level is ameasure of the intensity of a post MI patient's physical activities,such as the patient's heart rate, acceleration signal acquired by anaccelerometer implanted in the patient, and the patient's minuteventilation. In one embodiment, the activity level is compared one ormore predetermined thresholds, and the one or more pacing parameters areadjusted based on the outcome of the comparison. In one embodiment, theone or more pacing parameters to be dynamically adjusted include atleast one AV delay. In another embodiment, the one or more pacingparameters to be dynamically adjusted include at least one AV delay andone interventricular delay. In one specific embodiment, the AV delayand/or interventricular delay are adjusted by selecting from a pluralityof preset AV delay and/or interventricular delay values based on atleast the activity level. In one embodiment, the one or more pacingparameters to be dynamically adjusted include pacing channels. One ormore pacing channels are selected from a set of cardiac sites wherepacing electrodes are placed.

In one embodiment, a signal indicative of the patient's hemodynamicperformance is sensed. In one embodiment, the signal indicative of thepatient's hemodynamic performance is used to determine the one or morepacing parameters such as the AV delay, interventricular delay, andpacing channels. In one embodiment, the signal indicative of thepatient's hemodynamic performance is used to determine whether thedynamic pacing algorithm should be executed. In one further embodiment,the signal indicative of the patient's hemodynamic performance is usedto determine whether the execution should be interrupted or stopped.Examples of the signal indicative of the hemodynamic performance includethe patient's minute ventilation, S1 amplitude and duration, S3amplitude, LV+dp/dt, and stroke volume.

It is to be understood that the above detailed description is intendedto be illustrative, and not restrictive. For example, the method ofautomatically and selectively executing two or more therapy algorithmscan be applied to treat non-cardiac conditions, and not necessarily byusing an implantable device. Other embodiments, including any possiblepermutation of the system components discussed in this document, will beapparent to those of skill in the art upon reading and understanding theabove description. The scope of the invention should, therefore, bedetermined with reference to the appended claims, along with the fullscope of equivalents to which such claims are entitled.

1. An implantable pacemaker comprising: a sensing circuit to sense atleast one electrogram; a pacing circuit to deliver pacing pulses; anactivity sensor to sense an activity level; and a pacing controllercoupled to the sensing circuit, the pacing circuit, and the activitysensor, the pacing controller including: a dynamic pacing parametercontroller adapted to be activated by an activation signal and adaptedto dynamically adjust one or more pacing parameters based on at leastthe activity level after being activated; a myocardial infarctiondetector to detect a signal indicative of a myocardial infarction event;and a pacing algorithm selector adapted to generate the activationsignal after the signal indicative of the myocardial infarction event isdetected.
 2. The implantable pacemaker of claim 1, wherein the activitysensor comprises a heart rate monitor to detect a heart rate indicativeof the activity level.
 3. The implantable pacemaker of claim 1, whereinthe activity sensor comprises an accelerometer to sense an accelerationindicative of the activity level.
 4. The implantable pacemaker of claim1, wherein the activity sensor comprises a minute ventilation sensor tosense a signal indicative of a minute ventilation.
 5. The implantablepacemaker of claim 4, wherein the minute ventilation sensor comprises animpedance sensor.
 6. The implantable pacemaker of claim 1, wherein thedynamic pacing parameter controller comprises an atrioventricular (AV)delay adjuster adapted to dynamically adjusting at least one AV delaybased on at least the activity level.
 7. The implantable pacemaker ofclaim 6, wherein the AV delay adjuster comprises an AV delay selector todynamically select a value for the at least one AV delay from aplurality of predetermined AV delay values based on at least theactivity level.
 8. The implantable pacemaker of claim 6, wherein thedynamic pacing parameter controller further comprises aninterventricular delay adjuster adapted to dynamically adjusting atleast one interventicular delay based on at least the activity level. 9.The implantable pacemaker of claim 8, wherein the interventricular delayadjuster comprises an interventricular delay selector to dynamicallyselect a value for the at least one interventricular delay from aplurality of predetermined interventricular delay values based on atleast the activity level.
 10. The implantable pacemaker of claim 6,wherein the pacing circuit comprises a plurality of pacing channels todeliver the pacing pulses to a plurality of cardiac sites, and thedynamic pacing parameter controller comprises a pacing channel selectoradapted to dynamically select a predetermined set of one or more pacingchannels from the plurality of pacing channels based on at least theactivity level.
 11. The implantable pacemaker of claim 10, furthercomprising an activity level comparator to compare the activity level toone or more predetermined activity level thresholds, wherein the dynamicpacing parameter controller is adapted to control one or more pacingparameters based on at least the result of the comparison.
 12. Theimplantable pacemaker of claim 11, wherein the pacing algorithm selectorcomprises a timer to time a predetermined period starting when thesignal indicative of the myocardial infarction event is detected andactivate the dynamic pacing parameter controller after the predeterminedperiod expires.
 13. The implantable pacemaker of claim 1, wherein themyocardial infarction detector comprises a command receiver to receivean external activation command issued in response to the myocardialinfarction event, the external activation command being the signalindicative of the myocardial infarction event.
 14. The implantablepacemaker of claim 13, wherein the dynamic pacing parameter controllerfurther comprises a parameter receiver to receive values for the one ormore pacing parameters.
 15. The implantable pacemaker of claim 1,wherein the myocardial infarction detector comprises an ischemiadetector.
 16. The implantable pacemaker of claim 15, wherein theischemia detector comprises an electrogram-based ischemia detector. 17.The implantable pacemaker of claim 15, wherein the ischemia detectorcomprises an impedance sensor.
 18. The implantable pacemaker of claim15, wherein the ischemia detector comprises an accelerometer sensingcardiac wall motion.
 19. The implantable pacemaker of claim 1, furthercomprising a hemodynamic performance sensor to sense a signal indicativeof hemodynamic performance.
 20. The implantable pacemaker of claim 19,wherein the pacing controller comprises a signal analyzer to receive thesignal indicative of hemodynamic performance, and the pacing algorithmselector determines whether to activate or deactivate the dynamic pacingparameter controller based on the signal indicative of hemodynamicperformance.
 21. The implantable pacemaker of claim 20, wherein thehemodynamic performance sensor comprises an impedance sensor sensing asignal indicative of minute ventilation.
 22. The implantable pacemakerof claim 20, wherein the hemodynamic performance sensor comprises anacoustic sensor to sense heart sounds and a heart sound analyzer todetect first heart sounds (S1) and measure an S1 duration.
 23. Theimplantable pacemaker of claim 20, wherein the hemodynamic performancesensor comprises a pressure sensor to sense a signal indicative of aleft ventricular pressure and a pressure analyzer to calculate anmaximum positive derivative of the left ventricular pressure, LV+dp/dt.24. The implantable pacemaker of claim 20, wherein the hemodynamicperformance sensor comprises a stroke volume sensor to sense a signalindicative of stroke volume.
 25. A cardiac rhythm management system,comprising: an implantable medical device including: a sensing circuitto sense at least one electrogram; a pacing circuit to deliver pacingpulses; an activity sensor to sense an activity level; and a pacingcontroller coupled to the sensing circuit, the pacing circuit, and theactivity sensor, the pacing controller including: a dynamic pacingparameter controller adapted to be activated by an activation signal andadapted to dynamically adjust one or more pacing parameters based on atleast the activity level after being activated; a myocardial infarctiondetector to detect a signal indicative of a myocardial infarction event;and a pacing algorithm selector adapted to generate the activationsignal after the signal indicative of the myocardial infarction event isdetected; and an external system communicatively coupled to theimplantable medical device via telemetry, the external system includinga user input to receive commands controlling operations of the implantedmedical device.
 26. The cardiac rhythm management system of claim 25,wherein the myocardial infarction detector comprises a command receiverto receive an external activation command as the signal indicative ofthe myocardial infarction event, and the user input is adapted toreceive a user activation command and issue the external activationcommand in response to the user activation command.
 27. The cardiacrhythm management system of claim 26, wherein the user input comprisesan on/off selector allowing an entry of the user activation command byan on-selection.
 28. The cardiac rhythm management system of claim 26,wherein the dynamic pacing parameter controller further comprises aparameter receiver to receive values for the one or more pacingparameters, and the user input comprises parameter entry fields toreceive one or more values for the one or more pacing parameters. 29.The cardiac rhythm management system of claim 26, wherein theimplantable medical device further comprises a hemodynamic performancesensor to sense a signal indicative of hemodynamic performance.
 30. Thecardiac rhythm management system of claim 29, wherein the hemodynamicperformance sensor comprises the activity sensor.
 31. The cardiac rhythmmanagement system of claim 29, wherein the external system comprises asignal receiver to receive one or more of the at least one electrogram,the activity level, and the signal indicative of hemodynamicperformance.
 32. The cardiac rhythm management system of claim 31,wherein the external system comprises a presentation device to presentthe received one or more of the at least one electrogram, the signalindicative of hemodynamic performance.
 33. The cardiac rhythm managementsystem of claim 31, wherein the external system comprises an externalcontroller to issue the external activation command based on thereceived one or more of the at least one electrogram, the signalindicative of a measure of hemodynamic performance.
 34. The cardiacrhythm management system of claim 31, wherein the external systemcomprises a programmer.
 35. The cardiac rhythm management system ofclaim 31, wherein the external system comprises: an external devicecoupled to the implantable medical device via telemetry; a networkcoupled to the external device; and a remote device coupled to thenetwork.
 36. The cardiac rhythm management system of claim 35, whereinthe remote device comprises a presentation device and the user input.37. A method for operating an implantable pacemaker, comprising:detecting a signal indicative of a myocardial infarction event; andexecuting a dynamic pacing algorithm after the signal indicative of themyocardial infarction event is detected, the executing including:sensing an activity level; dynamically adjusting one or more pacingparameters based on at least the activity level; sensing at least oneelectrogram; and delivering pacing pulses.
 38. The method of claim 37,wherein sensing the activity level comprises detecting heart rate. 39.The method of claim 37, wherein sensing the activity level comprisessensing an acceleration signal.
 40. The method of claim 37, whereinsensing the activity level comprises sensing a signal indicative of aminute ventilation.
 41. The method of claim 37, wherein dynamicallyadjusting the one or more pacing parameters comprises dynamicallyadjusting at least one AV delay based on at least the activity level.42. The method of claim 41, wherein dynamically adjusting the at leastone AV delay comprises dynamically selecting a value for the at leastone AV delay from a plurality of predetermined AV delay values based onat least the activity level.
 43. The method of claim 41, whereindynamically adjusting the one or more pacing parameters furthercomprises dynamically adjusting at least one interventricular delaybased on at least the activity level.
 44. The method of claim 43,wherein dynamically adjusting the at least one interventricular delaycomprises dynamically selecting a value for the at least oneinterventricular delay from a plurality of predeterminedinterventricular delay values based on at least the activity level. 45.The method of claim 41, wherein dynamically adjusting the one or morepacing parameters further comprises dynamically selecting one or morepacing channels from a plurality of predetermined pacing channels basedon at least the activity level.
 46. The method of claim 37, whereindynamically adjusting the one or more pacing parameters comprisescomparing the activity level to one or more predetermined thresholdlevels and adjusting the one or more pacing parameters based on at leastthe result of the comparison.
 47. The method of claim 37, whereinexecuting the dynamic pacing algorithm comprises: timing a predeterminedtime period starting when the signal indicative of the myocardialinfarction event is detected; and starting to execute the dynamic pacingalgorithm upon an expiration of the predetermined time period.
 48. Themethod of claim 37, wherein detecting the signal indicative of themyocardial infarction event comprises receiving an external activationcommand from an external system communicating to the implantablepacemaker, the external activation command being the signal indicativeof the myocardial infarction event.
 49. The method of claim 48, furthercomprising receiving values for the one or more pacing parameters fromthe external system.
 50. The method of claim 37, wherein detecting thesignal indicative of the myocardial infarction event comprises detectingan ischemia.
 51. The method of claim 50, wherein detecting the ischemiacomprises detecting the ischemia from the at least one electrogram. 52.The method of claim 50, wherein detecting the ischemia comprises sensingan impendance.
 53. The method of claim 50, wherein detecting theischemia comprises sensing an acceleration indicative of a cardiac wallmotion.
 54. The method of claim 37, further comprising sensing a signalindicative of hemodynamic performance.
 55. The method of claim 54,further comprising adjusting the one or more pacing parameters based onthe signal indicative of hemodynamic performance.
 56. The method ofclaim 54, wherein sensing the signal indicative of hemodynamicperformance comprises sensing a signal indicative of minute ventilation.57. The method of claim 54, wherein sensing the signal indicative ofhemodynamic performance comprises sensing heart sounds, detecting firstheart sounds (S1), and measuring one or more of an S1 amplitude and anS1 duration.
 58. The method of claim 54, wherein sensing the signalindicative of hemodynamic performance comprises sensing heart sounds,detecting third heart sounds (S3), and measuring an S3 amplitude. 59.The method of claim 54, wherein sensing the signal indicative ofhemodynamic performance comprises sensing a signal indicative of a leftventricular pressure and calculating an maximum positive derivative ofthe left ventricular pressure, LV+dp/dt.
 60. The method of claim 54,wherein sensing the signal indicative of hemodynamic performancecomprises sensing a signal indicative of stroke volume.
 61. The methodof claim 54, further comprising transmitting the at least oneelectrogram, the activity level, and the signal indicative ofhemodynamic performance to an external system communicating with theimplantable pacemaker via telemetry.
 62. A cardiac pacing method,comprising: sensing an activity level; comparing the activity level to apredetermined threshold; executing a cardiac resynchronization therapy(CRT) pacing algorithm if the activity level exceeds the predeterminedthreshold; and executing a remodeling control therapy (RCT) pacingalgorithm if the activity level does not exceed the predeterminedthreshold.
 63. The method of claim 62, wherein sensing the activitylevel comprises sensing an acceleration.
 64. The method of claim 62,wherein sensing the activity level comprises sensing a minuteventilation.
 65. The method of claim 62, wherein sensing the activitylevel comprises sensing a heart rate.
 66. The method of claim 62,wherein: executing the CRT pacing algorithm comprises selecting a firstset of pacing parameter values; and executing the RCT pacing algorithmcomprises selecting a second set of pacing parameter values.
 67. Themethod of claim 66, wherein: selecting the first set of pacing parametervalues comprises selecting a first set of one or more pacing sites; andselecting the second set of pacing parameter values comprises selectinga second set of one or more pacing sites.
 68. The method of claim 66,wherein: selecting the first set of pacing parameter values comprisessetting at least one atrioventricular delay to a first time interval;and selecting the second set of pacing parameter values comprisessetting the at least one atrioventricular delay to a second timeinterval, wherein the first time interval is longer than the second timeinterval.
 69. The method of claim 68, wherein further comprisingdetermining the second time interval for an optimal left ventricularstress distribution.
 70. The method of claim 69, wherein furthercomprising determining the first time interval for a maximum positivederivative of the left ventricular pressure, LV+dp/dt.
 71. The method ofclaim 69, wherein further comprising determining the first time intervalfor a maximum stroke volume.